Lack of efficacy

The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.

Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus. Current epidemiologic evidence suggests that 80% of sexually active women will become infected during their lifetime with human papillomavirus and 50% of these infections will be due to high-risk human papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a very substantial number of women are left with uncertainty regarding whether their infection will clear spontaneously or progress to cancer.

Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of participation in this study was approximately 27 months.

Inclusion Criteria:

• Willing to be on acceptable method of birth control
• Have a Pap smear result of LSIL or ASCUS
• Is high risk HPV positive

Exclusion Criteria:

• No evidence of high-grade disease or glandular abnormalities,
• Complete visualization of all lesion margins and the transformation zone,
• No uncontrolled significant medical illness or sexually transmitted infections,
• Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.